Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Rare Diseases

Chronic Disease

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Quality of Life

Ovarian Cancer

Ovarian Epithelial Cancer

Chronic Graft Versus Host Disease

telephone-based intervention

counseling intervention

educational intervention

medical chart review

questionnaire administration

psychosocial assessment and care

quality-of-life assessment

Marcia Grant, RN, DNSc, FAAN

RATIONALE: A teaching intervention with an advanced practice nurse may help reduce psychosocial and symptom distress and improve the well-being and quality of life of patients with ovarian cancer.

PURPOSE: This clinical trial is studying the effects of a teaching intervention with an advanced practice nurse on quality of life and psychosocial and symptom distress in patients with ovarian cancer.

OBJECTIVES:

* To compare the effects of a standardized nursing intervention protocol (SNIP) model with an advanced practice nurse vs usual care on overall quality of life and psychological distress from initial treatment to 6 months after diagnosis in patients with ovarian cancer.
* To compare symptom control in these patients.
* To compare geriatric assessment outcomes in these patients.
* To compare the effects of the SNIP intervention vs usual care on resource use by these patients.
* To test the effects of SNIP on patients' and clinicians' satisfaction with care.
* To describe the effects of SNIP on management of transitions from one phase of chronic illness to another.
* To identify subgroups of patients with ovarian cancer who benefit most from the SNIP in relation to sociodemographic characteristics, disease/treatment factors, and geriatric assessment predictors.
* To obtain feedback from clinicians regarding interpretation of findings and application to the routine care of ovarian cancer patients.

OUTLINE: Patients are stratified according to age (18 to 60 years vs 61 years and over). Patients are sequentially enrolled into 1 of 2 groups. Patients are initially enrolled in group I. Once enrollment in group I is completed, additional patients are enrolled in group II.

* Group I (usual care): Patients complete questionnaires, including the FACT-Ovarian, Memorial Symptom Assessment Scale, Psychological Distress Thermometer, and Comprehensive Geriatric Assessment, at baseline and at 3 and 6 months. Clinicians also complete questionnaires, including the Clinician Satisfaction with Intervention Questionnaire. Patients' medical charts are reviewed to collect information about treatment, episodes of care, and readmissions.
* Group II (advanced practice nurse \[APN\] intervention): Patients undergo face-to-face individualized teaching sessions with an APN twice a month for 2 months. The sessions focus on the patient's physical, psychological, social, and spiritual well-being and the content is tailored to the patient's preferences and needs. Patients are then contacted by the APN via telephone once a month for 4 months to clarify questions and content from the teaching sessions, review any patient concerns, including concerns associated with a transition, and coordinate interdisciplinary resources, including community resources, as needed. Patients and clinicians complete questionnaires as in group I. Patients' medical charts are also reviewed.

Effects of a Teaching Intervention With an Advanced Practice Nurse on Quality of Life and Psychosocial and Symptom Distress in Patients With Ovarian Cancer

A Standardized Nursing Intervention Protocol for Ovarian Cancer as a Chronic Illness

National Cancer Institute (NCI)

City of Hope Medical Center

Marcia Grant

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Immune System Diseases

Recurrence

Esophageal Neoplasms

Death

Small Cell Lung Carcinoma

Cholangiocarcinoma

Breast Neoplasms

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Stomach Neoplasms

Sarcoma

Carcinoma, Renal Cell

Lung Neoplasms

Lymphoma

Urinary Bladder Neoplasms

Gastrointestinal Stromal Tumors

Liver Neoplasms

Breast Neoplasms, Male

Sarcoma, Ewing

Testicular Neoplasms

Neuroectodermal Tumors, Primitive, Peripheral

Kidney Neoplasms

Anus Neoplasms

Carcinoid Tumor

Leiomyosarcoma

Rhabdoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Sarcoma, Clear Cell

Esophageal Cancer

Small Cell Lung Cancer

Pancreatic Cancer

Bile Duct Cancer

Renal Cell Carcinoma

Stomach Cancer

Soft Tissue Sarcoma

Lymphosarcoma

Primary Liver Cancer

Gallbladder Cancer

Breast Cancer, Male

Germ Cells Tumors

Fallopian Tube Cancer

Penile Cancer

Anal Cancer

Transitional Cell Cancer of the Renal Pelvis and Ureter

Small Intestinal Adenocarcinoma

Testicular Germ Cell Tumor

Small Intestine Cancer

Neuroepithelioma

Urethral Cancer

Hematinics

All Drugs and Chemicals

Herbal and Botanical

Liver Extracts

Cola

telephone based ENABLE educational intervention

Supportive and palliative usual care services at DHMC, Behavioral

Marie A Bakitas, PhD

RATIONALE: Palliative care may help patients with advanced cancer live more comfortably.

PURPOSE: This randomized clinical trial is studying an early intervention palliative care program to see how well it works compared to a standard care program in improving end-of-life care in patients with advanced lung , gastrointestinal, genitourinary, or breast cancer.

OBJECTIVES:

* Determine the efficacy of an early intervention palliative care program comprising a phone-based nurse educator and shared medical appointments in improving end-of-life care of patients with advanced lung, gastrointestinal, genitourinary, or breast cancer.
* Compare symptom management, quality of life, and the match between preference of care and the care received in patients treated with an early intervention palliative care program vs a standard care program.
* Compare health care utilization by patients treated with these interventions.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to cancer diagnosis (lung vs breast vs gastrointestinal vs genitourinary) and participating center. Patients are randomized to 1 of 2 intervention arms.

* Arm I (early-intervention palliative care program): Patients complete the Medical Care Questionnaire and receive a computer-generated prescription letter that outlines the problems they have identified; the patient's physician also receives a copy of the letter. Patients receive a series of phone calls weekly for 4 weeks and then at least monthly from a nurse educator. The phone calls address 3 major areas: coordination of palliative care options in the cancer center and the patient's community, including referrals for psychological or spiritual counseling, social work consultation, financial guidance, home health, palliative care or hospice services, and bereavement counseling for the family; problem-solving therapy, focusing on the identification of problems, definition of achievable goals, a plan for reaching those goals, and evaluation of success; and tailored psycho-educational modules from "Charting Your Course", covering end-of-life topics such as symptom management, advanced care planning, communication with the health care team and family members, spirituality, and nutrition. Patients also receive information regarding the purpose and time/location of symptom management, shared medical appointments (SMAs), which they can attend in person or call in to participate via speaker phone. SMAs are 1.5-hour monthly sessions conducted by a physician and a nurse practitioner that can accommodate 10-12 patients and their caregivers. The sessions include a welcome/social period, a question and answer/peer discussion, an interactive educational session, and an opportunity for one-on-one nurse practitioner appointments with a focus on a brief review of the patients' medical treatment plans.
* Arm II (standard palliative care program): Patients receive standard palliative care from their physician/nurse practitioner team and have access to the palliative care nurse at the discretion of the treating physician.

Patients complete Functional Assessment of Chronic Illness Therapy-Palliative Care at baseline and every 3 months thereafter. Patients and caregivers complete surveys measuring their perception of the quality of the patient's cancer care at baseline and at 1 month.

A caregiver or family member completes the After-Death Bereaved Family Member Interview to evaluate the adequacy of patient care at 3 months post-patient death.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Early Intervention vs. Standard Palliative Care in Improving End-of-Life Care in Advanced Cancer Patients

Improving Palliative Care for Patients With Cancer

Dartmouth-Hitchcock Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of a Teaching Intervention With an Advanced Practice Nurse on Quality of Life and Psychosocial and Symptom Distress in Patients With Ovarian Cancer	NCT00900679	Ovarian Cancer Transitional Ca...	telephone-based... counseling inte... educational int... medical chart r... questionnaire a... psychosocial as... quality-of-life...	18 Years -	City of Hope Medical Center
Early Intervention vs. Standard Palliative Care in Improving End-of-Life Care in Advanced Cancer Patients	NCT00253383	Cancer	counseling inte... educational int... psychosocial as... quality-of-life...	18 Years -	Dartmouth-Hitchcock Medical Center

Spots Global Cancer Trial Database for transitional care planning